FDA Approves Dermal Filler for Hand Treatment

05/21/2018

The FDA has approved Restylane Lyft, a hyaluronic acid (HA) dermal filler, for the correction of age-related volume loss in the back of the hands for patients over the age of 21 years. This is the first FDA-approved HA dermal filler for the back of the hands, and the first HA dermal filler to receive approval for an area other than the face.

Approval of the HA dermal filler was based on a multi-center, randomized, trial that included 89 participants age 22 years and older. The HA dermal filler showed clinically meaningful improvements in the correction of volume deficits for up to 6 months and was safe and well-tolerated.

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The most common adverse events were injection site reactions including swelling, tenderness, redness, bruising, pain, itching, and impaired hand function, which were predominately mild and temporary.

The HA dermal filler is also indicated for mid-to-deep injection into the facial tissue to correct moderate to severe facial wrinkles and folds, and is indicated in combination with lidocaine for deep implantation into facial tissue for the correction of moderate to severe facial wrinkles and folds, as well as for cheek augmentation and age-related mid-face contour deficiencies.

Figure 1: Hand of clinical trial participant before and after 4 weeks of treatment with 3 mL of HA dermal filler.